Update: The following update relating to this announcement has been issued:

March 9, 2011 - See Notice NOT-TW-11-015 this Notice is being discontinued and, as of the date of this notice, FIC will no longer accept applications for this program.

December 13, 2010 - See Notice NOT-TW-11-005 This notice is to inform potential applicants that the competition for the AIDS International Training and Research Program (AITRP) (D43) has been suspended for the FY 2012 funding cycle.

August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections
must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

September 29, 2010 (NOT-OD-11-008) - Updated Electronic Application Forms Required for F, K, T and D Submissions with Due Dates of January 25, 2011 and Beyond. Adobe B1 forms are required for due dates on or after January 25, 2011.

Program Announcement
(PA) Number:PAR-10-219

Notice: Applications submitted in response to the
Funding Opportunity Announcement

(FOA) for Federal assistance must be submitted
electronically through Grants.gov(http://www.grants.gov) using the SF424 Research
and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE
SUBMITTED IN PAPER FORMAT.

This FOA must be read in
conjunction with the application guidelines included with this announcement in Grants.gov/Apply
for Grants (hereafter called
Grants.gov/Apply).

A registration process is
necessary before submission and applicants are highly encouraged to start the
process at least four (4) weeks prior to the grant submission date. See Section IV.

A
compatible version of Adobe Reader is required for download. For assistance
downloading this or any Grants.gov application package, please contact
Grants.gov Customer Support at http://grants.gov/CustomerSupport.

Key Dates
Release/Posted
Date: June 18, 2010
Opening Date: July 16, 2010 (Earliest date an application may be submitted to
Grants.gov)Letters of Intent Submission
Date(s):July 16, 2010;
July 16, 2011; July 16, 2012NOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization). Application Due Date(s): August 16, 2010; August 16, 2011(Suspended per NOT-TW-11-005); August 16, 2012Peer Review Date(s):October/November2010; October/November2011; October/November2012Council Review
Date(s):January 2011; January 2012; January 2013Earliest
Anticipated Start Date(s):April 1, 2011; April 1, 2012; April 1, 2013Additional Information To Be Available
Date (Activation Date):Not ApplicableExpiration
Date: (Now Expired March 9, 2011 per NOT-TW-11-015), August 17, 2012

Due Dates for E.O. 12372

Not Applicable

Additional
Overview Content

Executive Summary

Purpose.The Fogarty
International Center (FIC), togetherwith the
National Cancer Institute (NCI), the National Institute of Allergy and
Infectious Diseases (NIAID), the National Institute of Drug Abuse (NIDA),
the National Institute of Dental and Craniofacial Research (NIDCR), and
the National Institute of Nursing Research (NINR), encourages renewal and new applications in
the AIDS International Training and Research
Program (AITRP).
The application must propose a collaborative research training program
that will strengthen the capacity of institutions in low-and middle-income
countries (LMIC), defined by the World Bank classification system, to conduct HIV-relatedresearch.

Mechanism
of Support.This FOA will
utilize the D43 grant mechanism.

Funds Available and Anticipated Number of Awards. Because the nature and
scope of the proposed research education program will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. The total amount awarded and the number of awards will depend upon
thenumber of applications, the quality of those applications,
and the years of funding of renewal applications.

Budget
and Project Period.The expected amount for individual awards will vary.See guidelines for levels of funding under Section
II. Award Information 2. Funds Available.Facilities and Administrative
(F&A) costs requested by consortium participants are not included in the
direct cost limitation, see NOT-OD-05-004. Facilities and administrative costs are limited to 8% for
all awards and sub-awards.

Application Research Strategy Length: Items
2-5 of the Research Training Program Plan (Background, Program Plan,
Recruitment and Retention Plan to Enhance Diversity, and Plan for Instruction
in the Responsible Conduct of Research) are limited to a combined total of 25
pages, including tables, graphs, figures, diagrams, and charts.

Eligible
Institutions/Organizations.Institutions/organizations
listed in Section III, 1.A. are
eligible to apply. Applications from U.S. institutions must demonstrate collaborations with institutions in the low- and
middle-income countries (LMIC), defined by the World Bank classification system, named in their
application. Only foreign
institutions from LMIC who were awarded planning grants under previous
AITRP planning grant funding opportunity announcements (FOA) (https://grants.nih.gov/grants/guide/pa-files/PAR-07-348.html) may submit an application in response
to this FOA.

Eligible Project Directors/Principal Investigators (PDs/PIs): An eligible Training PD/PI is any individual with
the skills, knowledge, successful past training record, and available
resources necessary to carry out the proposed research training program.
The PD/PI should be an established researcher at the applicant institution.
The PD/PI will be responsible for the selection of eligible trainees to
the training grant, the overall direction, management and administration
of the research training program, program evaluation, and the submission
of all required forms in a timely manner. US applicants must identify at
least one scientist from each LMIC institution as the main foreign
collaborator for that institution. Women,
individuals from underrepresented racial, ethnic or socially
disadvantaged groups as well as individuals with
disabilities are always encouraged to apply for NIH support. The PD/PI and/or
key personnel listed in the application must be designated as the PD of at least one research
award that is directly relevant to the research training proposed and with
at least 18 months of support remaining at the time of submission of the
application.

Number of PDs/PIs. More than one PD/PI
(i.e., multiple PDs/PIs), may be designated on the application.

Number
of Applications. Only one application may be submitted from an institution
in a fiscal year under this FOA. Only one D43 AIDS International Training and Researchprogram award will be made to an institution
at any given time.

Resubmissions. Resubmission applications will be accepted. See new NIH
policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
Such application must include an Introduction addressing the previous peer
review critique (Summary Statement). (NOT-OD-09-003, NOT-OD-09-016).).

Renewals.Renewal applications areallowed for this research
education program.

The Fogarty International
Center (FIC), together with the
National Cancer Institute (NCI), the National Institute of Allergy and
Infectious Diseases (NIAID), the National Institute of Drug Abuse (NIDA), the
National Institute of Dental and Craniofacial Research (NIDCR), and the
National Institute of Nursing Research (NINR), encourages renewal and new applications in the AIDS International Training and Research (AITRP)program.
The application must propose a research training program that will strengthen
the capacity of institutions in low-and middle-income countries (LMIC), defined
by the World Bank classification system, to conduct HIV-related research.
The proposed research training program must be developed and implemented collaboratively
with all participating institutions (see Section III Eligibility Information).

The
Program Director/Principal Investigator (PD/PI) must have strong research and
research-training program experience, should include the requisite faculty in
the application, and have access to the requisite facilities to carry out the
proposed research training activities. The PD/PI and collaborators will be
responsible for the overall conduct of the grant. The role of the collaborators
in setting the research agenda and in conceptualizing and mentoring research
projects should be described in the application. All applicants should explain
in detail how their relevant research grant support and activities are related
to the proposed research training plan.

As the global HIV epidemic is
well into its third decade, the toll it has taken on individuals' lives is felt around the world. While currently the
highest numbers of affected populations are in countries in sub-Saharan Africa, people, particularly those in marginalized
populations, from around the world continue to be negatively impacted by HIV infection and its effects. While world-wide
efforts to provide care and treatment for HIV-infected people have expanded to
reach four million people, The Joint United Nations Program on HIV/AIDS(UNAIDS) estimates that an additional 9.7
million infected people are still in need. Current prevention efforts are
not stemming the tide of the epidemic; for every two people put on
treatment, five more become infected. HIV prevention efforts through the development of HIV vaccines or microbicides have been slow.
Male circumcision has been found to reduce the risk of female to male
transmission by 60%, but large- scale implementation of this intervention is
complex. Effective prevention programs focus on interventions that
reduce an individual’s risk behaviors, but the individual needs to adopt the interventions within a complex economic, legal, social and cultural
context.

To address the HIV epidemic
effectively, the capacity of LMIC institutions to conduct prevention, care and treatment
research across the full range of conditions and
issues that relate to HIV/AIDS in their country needs to continue to be
strengthened and expanded. In addition to research that leads to the
identification of new interventions, LMIC institutions also need to have the capacity to conduct research to evaluate the health, social
and economic outcomes and impacts of their HIV programs to guide policy makers as they develop new
policies and programs to address the HIV epidemic in their countries.

In 2009, President Obama announced
a six-year Global Health Initiative (GHI) (http://www.pepfar.gov/ghi/index.htm. GHI will focus on HIV/AIDS,
malaria, tuberculosis, neglected tropical diseases, maternal, neonatal and
child health, nutrition, family planning and
reproductive health, safe water and health systems strengthening.One of the GHI’s principles is
promoting research and innovation. GHI implementation will build on the
existing US government efforts in global health, including relevant
FIC research and research training programs.

Over its 22 year history, the research training provided in
the AIDS International
Training and Research Program (AITRP) awards has responded to the evolving HIV-related
research agenda in LMICs. The initial awards in 1988-92 were focused on short
term lab and epidemiology training for individual scientists from LMICs. Now,
the awards are focused on strengthening research and research training capacity
in the LMIC institutions to address biomedical, behavioral, social science and
implementation research questions around HIV-related prevention, care and
treatment. Thus, the AITRP supports all five goalsidentified in the FIC Strategic Plan
2008-2012 (http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm), including bridging the implementation research training gap and
strengthening a sustainable research environment in LMICs. The research training under the
AITRP involves
a wide range of health professionals (e.g. nurses,
midwives, physicians, dentists, health care administrators and public health
workers), and reaches across the span of basic sciences, clinical care and public health practice to
contribute to the development of new approaches and
adaptation of existing methodologies to address the whole array of
HIV-related research questions.

AITRP also supports training in skills for core research support functions which are required by an institution to
successfully compete for research funding and to conduct research.

The participating NIH ICs or other
co-sponsors especially encourage training for research
topics relevant to their missions. For more information, see the websites and
contacts listed in this FOA and additional information below:

Special
Program Objectives and Considerations

The
objectives of the AIDS
International Training and Researchprogram are:

To
develop research training programs to strengthen the capacity to conduct HIV-related researchat
LMIC institutions. Overtime, these institutions are expected to become
national, regional and international centers of expertise in HIV-related research;

To
develop a cadre of HIV-related research
experts who can address issues of importance and are most likely to contribute to science and affect public health policy in their country;

To support
training-related research (degree-related or mentored research projects) that is
directly relevant to the HIV-related health
priorities of the LMIC;

To
strengthen the research and research training capacity required for success by
building on existing research and public health programs in the LMIC.

To
strengthen core research support capabilities needed to manage research and
research training grants at the LMIC institution: expertise in ethics and compliance issues, protection for
human subjects, animal welfare, fiscal management, budgeting, program and
grants administration, grant and report writing, preparation of scientific
manuscripts, information technologies, technology
transfer and management of intellectual property, data management, and Internet
connectivity.

The mission of the National Institute of Dental and
Craniofacial Research (NIDCR) is to improve oral, dental, and craniofacial
health through research, research training, and the
dissemination of health information. NIDCR will consider providing
co-funding to grantees that identify and enroll trainees who are pursuing
careers in basic, translational and/or clinical research in oral and
craniofacial health aspects related to HIV infection.
More information regarding NIDCR’s priorities in this field may be found
at http://www.nidcr.nih.gov/Research/DER/IntegrativeBiologyAndInfectiousDiseases/AIDSImmuno.htm.

The mission of the National
Institute on Drug Abuse (NIDA) HIV/AIDS Research Program focuses on the role of
injection and non-injection drug use and their related behaviors in the
evolving dynamics of HIV/AIDS epidemiology, natural history/pathogenesis,
co-morbidities, treatment, medical consequences, and prevention. Under this
partnership with FIC, NIDA will consider providing co-funding to applicants for
research training and capacity building in all these facets of drug use as they
relate to HIV/AIDS. More information regarding NIDDA’s priorities in
this field may be found at http://www.drugabuse.gov/about/organization/arp/index.html.

The mission of the
National Institute of Allergy and Infectious Diseases (NIAID) conducts and
supports research—at NIH, throughout the United States, and worldwide—to study
the causes of infectious and immune-mediated diseases, and to develop better
means of preventing, diagnosing and treating these illnesses. NIAID will
consider providing co-funding to grantees that identify and enroll trainees who
are pursuing careers in basic, translational and/or clinical research in areas
related to the basic biology of the HIV virus and the immune response as well
as HIV/AIDS prevention and therapeutics, including the treatment of
co-infections, such as tuberculosis. More information regarding NIAID’s
priorities may be found at http://www.niaid.nih.gov/Pages/default.aspx

The mission of the National Institute of Nursing Research (NINR) supports clinical and basic research and research training
on health and illness across the lifespan. NINR
places great emphasis on research training to cultivate the next generation of
nurse scientists, as well as other biobehavioral researchers whose work
advances nursing science. Additional information about NINR’s Mission is
available at:http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan.

The mission of the
National Cancer Institute (NCI) in supporting training that will particularly
enable enhanced research capacity in epidemiology, pathogenesis, management and
optimal care for malignancies occurring in HIV infected individuals. As more
HIV+ people have access to treatment and care, and begin to live longer, cancer
will be among leading causes of mortality and morbidity. Such research training
in low- and middle-income countries is therefore needed to effectively optimize
comprehensive HIV care. Additional information about NCI’s mission is
available at: http://www.cancer.gov/.

The AITRPprogram
funds institutional research training awards that support training programs
designed to strengthen the capacity of the LMIC institution to conduct
independent research through the career development of individual researchers
and key personnel. The program is not an individual training fellowship
program. The trainees are expected to contribute to the research capacity in
the LMIC upon completion of their training.

Types
of Training: The
program application should incorporate an appropriate mix of long-, medium- and
short-term training opportunities to address the HIV-related research training needs identified for the LMIC. The training can be in basic biomedical or
clinical sciences; behavioral or social sciences; prevention research; health
services, operations and implementation research. Applicants are encouraged to design multidisciplinary research
training programs. The proposed training is expected to strengthen sustainable
research and core research
supportcapacity at the LMIC institution. Training can take place in the U.S. or a foreign country, but training-related research should be carried out mainly in the LMIC.
While a range of short-, medium- and long-term training is allowed, emphasis
will be on medium- to long-term training, including mid-career training and
advanced in-country research.

The
following types of training are included, but not limited to:

Long-term
(master’s or doctoral degree and other training that is six months or longer)
training for the full range of skills necessary to support research and research
administration with the
understanding that the focus of thesis and training-related research will be in
their country. Part time long term training is permitted but should be
described and justified in the application.

Medium-term
(three- to up to six-months) training or mentoring, including specialized
clinical, laboratory, research or administrative/business skills necessary to
support research that is planned or ongoing.

Short-term
(less than three months) training or mentoring that focuses on research
methodology, laboratory skills necessary to support research ethics and
compliance issues, program and grants administration, accounting, financial
management, grant writing, peer review, preparation of scientific manuscripts,
data management, Internet connectivity, technology transfer, medical
informatics, and other relevant areas.

Additional
institutional capacity-building efforts are encouraged. These may include, but
are not limited to, in-country training workshops in advanced techniques;
distance learning; and interaction with other national and regional efforts to
strengthen the ability of institutions to support research and research
training.

Advanced
in-country mentored research undertaken by the trainee in his/her home country
upon completion of his/her initial period of long-term training under the
program (master’s, Ph.D., post-doctoral or other long term training).

All training-related research projects in which trainees are
involved under this award must be independently peer-reviewed through scientific
review procedures established by the applicant institution, and have written
evidence of documentation of education in the protection of human subjects for
the trainee, compliance with the required federal citations, and approval from
an institutional (or ethical) review board or committee at the applicant
institution and, if different, at the LMIC institution in which the research is
being conducted. Please see: Procedures for Registering Institutional Review
Boards and Filing Federal-Wide Assurances of Protection for Human Subjects
(FWAs) at http://www.hhs.gov/ohrp/assurances/assurances_index.html.

Where appropriate, the design of training-related research
projects should take into account potential sex and
gender differences that may affect the questions asked and the analyses
performed. These might include different responses to and impacts of health
interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

When
a specific scientific course is given by one grantee, it is expected that this
course may be widely publicized and open to trainees of the other grantee
institutions under the AITRPprogram.

The AITRP program strongly encourages principal
investigator/program directors (PIs/PDs) to include women and individuals from
underrepresented racial, ethnic or socially disadvantaged groups in the country
as faculty at all sites.

This FOA will
use the D43 award mechanism.The
Project Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.

This
FOA uses the non-modular budget format and “Just-in-Time” information concepts
(see SF424 (R&R) Application
Guide). A
detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application, following the Instructions for preparing a D43 institutional
research training application described in Section IV 6A.

2.
Funds Available

Because the
nature and scope of the proposed research training will vary from application
to application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.

The expected amount for individual awards
will be up to:

$695,000per year (total direct costs) for up to ­­­­­­five years
for renewal applicants entering their 16th or greater year of
funding

$ 556,000per year (total direct costs) for up to ­­­­­­five
years for renewal applicants entering their 11th year of funding

$ 417,000per year (total direct costs) for up to ­­­­­­five
years for renewal applicants entering their 6th year of funding

$278,000per
year (total direct costs) for up to ­­­­­­five years for new applicants.

Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation, see NOT-OD-05-004. Facilities and administrative costs are limited to
8% for all awards and sub-awards.

Future
year amounts will depend on annual appropriations.

NIH
grants policies as described in the NIH Grants Policy
Statement will apply to the applications submitted and awards made in
response to this FOA.

2A. Allowable
Costs

Stipends: Stipends are provided
as a subsistence allowance for trainees to help defray living expenses during
the research training experience. Trainees may be paid a stipend comparable to
their professional experience. Applicants should use an appropriate stipend
level and can use the NRSA levels (seeKirschstein-NRSA
stipend schedule,) or grantee institutional policies for trainees involved
in medium- or long-term training. Partial stipends
for part time long-term trainees should reflect the amount of time they need to
be supported for training in the budget and described in the budget
justification.

Tuition and Fees: Funds for
tuition and academic fees at the U.S. or foreign institution may be
requested. Programs are encouraged to seek cost-sharing arrangements with
the grantee institutions in order to provide reduced tuition for trainees. Note
that health insurance is not included as part of this budget category, and is
now included under Training Related Expenses category. Tuition and fees
are excluded from the F&A base. Health insurance is included in the F&A
base.

Trainee Travel: Funds may be
requested for round-trip economy class airfare on U.S. carriers (to the maximum
extent possible). Funds may be requested for lodging and per diem for
short-term trainees. Funds may be requested to support participation in meetings in
which current or former trainees will be presenting training-related research
results.

Training-related Expenses: Applicants are encouraged to budget adequate professional development
opportunities for trainees, including international scientific conference
attendance. Training-related expenses (e.g., books, computers, and
courses for software, English language proficiency, etc.) may be included but
must be described in the budget justification. Funds for self-only or
family medical insurance may be requested. Include costs for logistics for
short- term courses and describe in budget justification.

One-time advanced in-country research training support of
up to $15,000 direct costs for mentored research to be undertaken by a long-term trainee in
his/her country upon completion of their training.

Salary for Senior/Key Personnel: The salary for the PD, other training faculty and administrative staff must be
commensurate with the salary structure and benefits at the institution where
they are employed and within the limits described at https://grants.nih.gov/grants/policy/salcap_summary.htm.

Collaborators may receive appropriate compensation for
their significant activities on the program, such as recruitment and selection
activities, as well as other program-related roles. The administrative,
training or teaching responsibilities and time commitment for personnel
receiving salary should be thoroughly described. The
salary and fringe benefits for the faculty and staff should not exceed 25
percent of total direct costs.

Faculty Travel:Funds
may be requested for round-trip economy airfare on U.S. carriers (to the
maximum extent possible) and lodging and per diem for the applicant to attend
the annual program network meeting, normally in the U.S. Principal
Investigators are expected to attend. Applicants
may also budget for grant administrators, other faculty, collaborators and
trainees to attend. Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for faculty providing
training at the foreign site.

Facilities
and Administrative (F&A) Costs: F&A costs for the applicant organization
and consortium participants will be reimbursed at 8 percent of modified total
direct costs, exclusive of tuition, fees, equipment, and consortia costs in excess of $25,000, per NIH Grants
policy for institutional research training grants https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm#_Toc54600212

NIH
grants policies as described in the NIH Grants Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Applications may be submitted by eligible
foreign institutions in the low- and middle-income countries (LMIC) and by eligible domestic (U.S.) institutions that demonstrate collaborations with LMIC
institutions named in their application.

Taiwan is not listed in the World Bank
income classification list but is considered high-income and therefore is not
eligible. Hong Kong is listed as high-income in the World Bank income
classification list, so is not considered a LMIC.

The proposed research training program must take advantage of on-going
research at the LMIC institution. This research does
not need to be NIH-funded, but it needs to be active and able to
support the proposed research training program. If the applicant is an U.S. institution, the research must be active and conducted in collaboration with the LMIC
institutions named in the application.

Applicants from LMIC institutions must document on-going relevant
research at the LMIC institution, which can support the proposed research
training program.

Applicants from LMIC institutions should apply in collaboration
with U.S. institutions capable of enhancing their proposed research training
opportunities, and must name an individual at the proposed U.S. collaborating institution as the major collaborator.

1.B.
Eligible Individuals

Any individual(s) with the
skills, knowledge, and resources necessary to carry out the proposed research training
as the PD/PI is invited to work with his/her organization to develop an
application for support. Women and individuals from underrepresented racial, ethnic
and socially disadvantaged groups as well as individuals with disabilities are
always encouraged to apply for NIH support.

The
proposed PD/PI must have strong research and research-training program
experience, should include the requisite faculty in the application, and have
access to the requisite facilities to carry out the proposed research training
activities.

The
proposed PD/PI must name at least one individual at each collaborating institution
as the major collaborator for that institution. Individuals chosen as major
collaborators should be scientists with whom the Principal Investigator or key
personnel named in the application have had prior successful collaborations.
These collaborations should be described in the application.

The
PI and collaborators will be responsible for the overall conduct of the grant. The
role of the collaborators in setting the research agenda and in conceptualizing
and mentoring research projects should be described in the application.

All
applicants should explain in detail how their relevant research grant support
and activities are related to the proposed research training plan.

The PD/PI and/or key personnel listed in the applicationmust be designated
as the PD of at least one active (with at least 18 months of support remaining
at the time of submission of the application) research award that is directly
relevant to the research training proposed. The research grants may be funded
by the NIH or by other national or international
organizations.The research award made to U.S. applicants must involve the LMIC institutions named in the application, and the
applicants need to document this existing research support in their
application. If 18 months will not remain in the
parent grant award period at the time of application submission, an applicant
must provide documentation that a renewal of a research grant to meet the
eligibility requirement is expected, that a no-cost extension has been/will be
requested for the research grant to meet the eligibility requirement and it
will have sufficient remaining resources to continue the research project, or
that other research support will be available to meet the eligibility
requirement.

Applications
with multiple Training PD/PIs must provide a Leadership Plan that emphasizes
how leadership by multiple PD/PIs will benefit the research training program
and the trainees. A single Contact PD/PI must be designated for the purpose
of communicating with the NIH, although other individuals may contact the NIH
on behalf of the Contact PD/PI when necessary. Because training
programs are intended to be coherent a single award will be made. NIH
will not allocate the budget or training positions between multiple PD/PIs.
Multiple PD/PI applications should include reasonable numbers of PD/PIs and
each should be included for a specific purpose. Multiple PD/PI applications
should not include all mentors of the training grant as PD/PIs, except
in unusual cases.

Additional instructional information
associated with the multiple PD/PI option is located in Section 8 of the
Application Guide instructions 8.10.10 (multiple PD/PI Leadership Plan). For
background information on the Multiple PD/PI initiative, see Multiple Principal Investigators..

2. Cost
Sharing or Matching

This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria

Number
of Applications. Only one application may be submitted from an institution
in a fiscal year under this FOA. Only one D43 AITRP award will be made to an institution at any given time. Applicants are
encouraged to check at their institutions and with FIC Scientific Research
Contact listed in Section VIII. Agency Contact to confirm that
there are not competing applications or existing awards in the AITRP. A new applicant froma LMIC institution will need to demonstrate in its applications (See PHS 398 Research Training Program Plan Components, Background Item 2) that the
research training being proposed will not be duplicative of research training being
provided by US AITRP awardees who provide research in collaboration with the
LMIC institution.

Resubmissions. Resubmission
applications will be accepted. See new NIH policy on resubmission (amended)
applications (NOT-OD-09-003, NOT-OD-09-016).
Such application must include an Introduction addressing the previous peer
review critique (Summary Statement). (NOT-OD-09-003, NOT-OD-09-016).).

Renewals.Renewal applications areallowed for this research
education program.

Trainee
Eligibility.
In the context of this FOA, “trainees” should be from the LMIC for which the
research training program is being designed.

A
limited number of training opportunities may be provided LMIC
individuals whose prior professional education does not include a bachelor's level degree (e.g., nurses,
midwives, laboratory technicians, and administrative staff) without bachelor
degrees, but with demonstrated interest and
capability to contribute to research. However, the majority of research
training provided under this award is expected to be to citizens of the LMIC at
the master’s, doctoral or post-doctoral level.

The AITRP program strongly encourages
principal investigator/program directors (PIs/PDs) to include women and
individuals from underrepresented racial, ethnic or socially disadvantaged
groups in the country as trainees.

Section IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for
Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.

Registration:

Appropriate
registrations with Grants.gov and eRA Commons must be completed on or before
the due date in order to successfully submit an application. Several of the
steps of the registration process could take four weeks or more for U.S. institutions and even longer for foreign institutions. Therefore, applicants
should immediately check with their business official to determine whether
their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations. All registrations must be complete by the submission
deadline for the application to be considered “on-time” (see 3.C.1 for more
information about on-time submission).

A one-time registration
is required for institutions/organizations at both:

If
your organization does not have a Taxpayer Identification Number (TIN) or
Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN
is necessary for CCR registration in the U.S. but is not required for foreign institutions
(See https://www.bpn.gov/ccr/StartRegistration.aspx).

The individual(s) designated as
PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned
the PI role in the eRA Commons prior to the submission of the application.

Each PD/PI must
hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a
PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist
under one Commons account.

When multiple PDs/PIs are
proposed, all PDs/PIs at the applicant organization must be affiliated with
that organization. PDs/PIs located at another institution need not be
affiliated with the applicant organization, but must be affiliated with their
own organization to be able to access the Commons.

This registration/affiliation must
be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PD(s)/PI(s)
and AOR/SO need separate accounts in the NIH eRA Commons since both are
authorized to view the application image.

Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. Some fields within the SF424 (R&R) application components, although
not marked as mandatory, are required by NIH (e.g., the “Credential” log-in
field of the “Research & Related Senior/Key Person Profile” component must
contain the PD/PI’s assigned eRA Commons User ID). Agency-specific
instructions for such fields are clearly identified in the Application Guide.
For additional information, see “Frequently Asked Questions – Application
Guide, Electronic
Submission of Grant Applications.”

The SF424 (R&R)
application has several components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components:

Multiple PD/PIs: More than one Training PD/PI (or multiple
PD/PIs), may be designated on the application for research training programs
that require a team approach and therefore clearly do not fit the single PD/PI
model, e.g., interdisciplinary or multidisciplinary training. The
decision to apply with a single PD/PI or a multiple PD/PIs is the
responsibility of the investigators and applicant organizations, and should be
determined and justified by the goals of the training program.
Applications for grants with multiple PD/PIs require additional
information. When considering multiple PD/PIs, please be aware that the
structure and governance of the PD/PI leadership team as well as the knowledge,
skills and experience of the individual PD/PI will be factored into the
assessment of the overall scientific merit of the application. Multiple
PD/PIs on a program share the authority and responsibility for leading and
directing the research training program, intellectually and logistically.
Each PD/PI is responsible and accountable to the grantee organization for the
proper conduct of the program, including the submission of required reports.

Because training programs are intended to be coherent a
single award will be made. NIH will not allocate the budget or training
positions between multiple PD/PIs. Multiple PD/PI applications should
include reasonable numbers of PD/PIs and each should be included for a specific
purpose. Multiple PD/PI applications should not include all mentors of
the training grant as PD/PIs, except in unusual cases.

When multiple PDs/PIs
are proposed, NIH requires one PD/PI to be designated as the "Contact” PI,
who will be responsible for all communication between the PDs/PIs and the NIH,
for assembling the application materials outlined below, and for coordinating
progress reports for the project. The contact PD/PI must meet all eligibility
requirements for PD/PI status in the same way as other PDs/PIs, but has no
other special roles or responsibilities within the project team beyond those
mentioned above.

Information for the
Contact PD/PI should be entered on the SF424 (R&R) Cover
component. All other PDs/PIs should be listed in the Research &
Related Senior/Key Person component and assigned the project role of
“PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included
in the “Credential” field of the Research & Related Senior/Key Person
component. Failure to include this data field will cause the application
to be rejected.

All projects proposing Multiple PDs/PIs will
be required to include a new section describing the leadership plan approach
for the proposed project.

Multiple PD/PI Leadership Plan:All
projects proposing Multiple PDs/PIs will be required to include a new section
describing the leadership plan approach for the proposed project. The Leadership Plan that emphasizes how leadership by
multiple PD/PIs will benefit the research training program and the trainees.For applications designating multiple PDs/PIs, the section
of the Research Training Plan, entitled “Multiple PD/PI Leadership Plan” [,
must be included. A rational for choosing a multiple PD/PI approach should be described. The
governance and organizational structure of the leadership team and the research
project should be described, and should include communication plans, process
for making decisions on scientific direction, and procedures for resolving
conflicts. The roles and administrative, technical, and scientific
responsibilities for the project or program should be delineated for the
PDs/PIs and other collaborators.

Prospective
applicants are asked to submit, preferably by email, a letter of intent that
includes the following information:

Descriptive title of proposed research training.

Name, address, and telephone number of
the PD(s)/PI(s).

Names of other key personnel.

Participating institutions, including those in the LMIC.

Number and title of this funding
opportunity.

Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.

To submit an
application in response to this FOA, applicants should access this FOA via http://www.grants.gov/web/grants/applicants/apply-for-grants.html and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All
attachments must be provided to NIH in PDF format, filenames must be included
with no spaces or special characters, and a .pdf extension must be used.

3.C.
Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application due date(s). (See Section
IV.3.A. for all dates.) If an application is not submitted by the due date(s)
and time, the application may be delayed in the review process or not reviewed. All
applications must meet the following criteria to be considered “on-time”:

All
registrations must be complete prior to the submission deadline

The
application must receive a Grants.gov tracking number and timestamp (or eRA
help desk ticket confirming a system issue preventing submission) by 5:00 p.m.
local time on the submission deadline date.

Any
system identified errors/warnings must be corrected and the submission process
completed within the “error correction window.”

Submission to Grants.gov is not the last step –
applicants must follow their application through to the eRA Commons to check
for errors and warnings and view their assembled application!

3.C.2. Two Day Window to Correct eRA Identified
Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond.
As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See
NOT-OD-10-123.

Once an application package has been
successfully submitted through Grants.gov,NIH provides
applicants a two day error correction window to correct any eRA
identified errors or warnings before a final assembled application is created
in the eRA Commons. The standard error correction window is two (2) business
days, beginning the day after the submission deadline and excluding weekends
and standard federal holidays. All errors must be corrected to successfully
complete the submission process. Warnings will not prevent the application
from completing the submission process.

Please note that the following
caveats apply:

Initial
application submission must be “on-time.”

The
AOR/institutions is expected to enforce that application changes made within
the error correction window are restricted to those necessary to address
system-identified errors/warnings. NIH may reject any application that
includes additional changes.

Proof of “on-time” submission (e.g., Grants.gov timestamp and
tracking number) and description of all changes made within the window must be
documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the
eRA Commons

Once any eRA identified errors have been
addressed and the assembled application has been created in the eRA Commons, the PD/PI and
the Authorized Organization Representative/Signing Official (AOR/SO) have two
weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it
automatically moves forward to NIH for further processing.

If everything is
acceptable, no further action is necessary. The application
will automatically move forward to the Division of Receipt and Referral in
the Center for Scientific Review for processing after two weekdays,
excluding Federal holidays.

Prior to the submission
deadline, the AOR/SO can “Reject” the assembled application and submit a
changed/corrected application within the two-day viewing window. This
option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process, the AOR/SO will have the option to “Reject” the application and
submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to
ensure that the issues are addressed and corrected. Once rejected,
applicants should follow the instructions for correcting errors in Section
2.12 of the SF 424 (R&R) application guide, including the requirement
for cover letters on late applications. The “Reject” feature should also be used if you determine that
warnings are applicable to your application and need to be addressed now.
Remember, warnings do not stop further application processing. If an application
submission results in warnings (but no errors), it will automatically move
forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn’t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and
determine the best course of action. NIH will not penalize the applicant for an
eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
late policy guidelines and may not be accepted. The reason for this delay should be
explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two weekdays.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.

There
will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
their application status in the Commons.

The NIH will not accept any application in response to
this FOA that is essentially the same as one currently pending initial merit
review unless the applicant withdraws the pending application. The NIH will not
accept any application that is essentially the same as one already reviewed.
However, the NIH will accept a resubmission application, and such
application must include an Introduction (limited to 3 pages) addressing the critique from
the previous review.

All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.

Funds for continuation support beyond the
initial year are determined by the success as described in the annual progress
report, the timely submission of required forms, and the availability of funds
for continuation programs.

Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or renewal
award if such costs: 1) are necessary to conduct the project, and 2) would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement: https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

The applicant organization
must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with
Grants.gov. For additional
information, see “Frequently Asked Questions – Application Guide, Electronic
Submission of Grant Applications.”

SF
424 Research and Related (R&R) Cover Component - Item 12. Proposed Project Start
and Ending Dates - Use
the dates that are given in the FOA for the program to which you are applying.

SF 424R&R Project/Performance Site Locations
Component - Include the applicant
institution and all of the collaborating institutions, both U.S. and foreign as performance sites.

SF 424 R&R Other Project Information Component:

Item
6. Foreign Award or With Foreign Component- Check YES and
list the foreign countries in 6a for all of the performance sites that you
listed in SF 424 (R&R) Project/Performance Site Locations Component.

Item 7. Be sure
to list the names of the LMIC in the Project Summary and Abstract.

Item 8. Describe
the public health relevance to the LMIC in Project Narrative.

Item 10. Include
descriptions for all of the performance sites in the attachment for Facilities
and Other resources.

SF 424 Senior/Key Person
Profile (Expanded) Component –Also,
include at least ONE person at each of the U.S. and foreign collaborating
institutions as senior/Key Personnel and list their role
as “Collaborator.” List all members of the Training Advisory Group (See 8.9.3
a Program Plan: Program: Program Administration for a description of the
Training Advisory Group) as Senior/Key Personnel and list their role as TAG
member. Be sure to attach bio-sketches for the
collaborators and TAG members. Attach current and pending support documentation
for collaborators.

PHS 398
Checklist

Item 3. Inventions and Patents- This block is optional and only applicable for a Renewal
application. If no inventions were conceived or reduced to practice during the
course of work under this research training grant, check the No box. The
remaining parts of the item are then not applicable. If any inventions were
conceived or reduced to practice and supported by the research training grant,
check the Yes box. If you checked the Yes box for Inventions and Patents,
above, indicate whether this information has been reported previously to the
PHS or to the applicant organization official responsible for patent matters.

Budget Pages: Use PHS 398 Training Budget Pages for trainee
specific expenses and the 424 R&R Budget pages for faculty and
personnel-related expenses. Budget forms should be
completed for each year (“Period”) for which funding is being sought. Follow
the instructions below and refer to the relevant FOA specific allowable
costs.

Training-related
expenses for Periods 1 through 5

Use
PHS 398 Training Budget Pages

Part
A. Stipends and Tuition/Fees

Use
the following instructions for categorizing the trainees since each application
will have trainees with a mix of educational backgrounds and a mix of proposed
training. Provide details of trainees in the budget justification and
identify, by name, any continuing trainees.

NIH
defines a Postdoctoral scholar as “an individual who
has received a doctoral degree (or equivalent) and is engaged in a temporary
and defined period of mentored advanced training to enhance the professional
skills and research independence needed to pursue his or her chosen career path
(https://grants.nih.gov/grants/glossary.htm#P)”.

Enter the number of trainees for degree training (master’s and
doctoral level) in the section labeled “Predoctoral”, for those without a
doctoral degree, (MD, PhD etc.). Request tuition for the degree program and a
stipend level appropriate for the educational background of the trainee and
location of training.

Enter the number of post doctoral trainees (prior doctoral degree)
non-degree seeking and degree seeking as indicated. Request any necessary
tuition and a stipend level appropriate for the educational background of the
trainee and location of training.

Enter the number of trainees without a prior doctoral degree and
who will receive non-degree training in the section labeled “Other.” Request any necessary
tuition and a stipend level appropriate for the educational background of the
trainee and location of training.

Current
NRSA stipend levels may be used as a guide and are described at Kirschstein-NRSA stipend
schedule, If a category contains different stipend levels, e.g., for
varying levels of postdoctoral experience and/or varying appointment periods,
itemize in the appropriate blocks. Enter the total stipends and tuition for all
categories. Partial stipends
for part time long term trainees should reflect the amount of time they need to
be supported for training in the budget and described in the budget
justification.

Note
that health insurance is not included as part of this budget category, and is
now included under Training Related Expenses category.

Part
B. Other Direct Costs

Enter
the total costs for Trainee Travel, Training Related Expenses, Total Direct
Costs from R&R Budget Form and Consortium Training Costs (if applicable).

Consortium
Training Costs (if applicable) -If training occurs at more than one institution, and
any transfer of funds between institutions occurs, the Training Sub-award
Budget Attachment Form should be used for each sub-award institution for each
period for which trainee funding is being sought. (See Section 4.8 of the
Grants.gov SF 424 R&R Application Guide). Total the direct costs from each
of the Training Sub-award Budget Attachment Forms for the period and insert
here. The applicant institution is responsible and accountable for any
arrangements, expenditures, and submission of all required forms when more than
one institution is involved in the research training program.

Use
Section F to attach one pdf file with detailed budget justification for
training costs for the applicant and any sub-award institutions.

Faculty
and Other Personnel-Related Expenses

Use
SF 424 R&R Budget Form, Periods 1 through 5

Use
Section A to submit costs for Senior/Key personnel.

Use
Section B to enter salary support for administrative staff.

Use
Section D to submit costs for key personnel and faculty travel including annual
network meeting.

Use
Section F for other costs and describe fully in budget justification. If
consortium sub-awards include costs for faculty and administrative expenses,
total these consortium costs for the period and include here.

Consortium Training Costs (if applicable)

If funding is sought for
faculty and administrative costs at consortium institutions, SF 424 R&R
Budget Forms should be used for each sub-award institution for each period for
which trainee funding is being sought. (See Section 4.8 of the Grants.gov SF
424 R&R Application Guide). Total the direct costs from each of the sub-award
SF 424 R&R Budget Forms Budget forms for that period and insert here. The
applicant institution is responsible and accountable for any arrangements,
expenditures, and submission of all required forms when more than one
institution is involved in the research training program.

PHS 398 Training Budget, Cumulative Budget

All values on this form are calculated automatically. They
present the summations of the amounts that you have entered previously, for
each of the individual budget periods. Therefore, no data entry is allowed or
required.

If
any of the amounts displayed on this form appear to be incorrect, you may
correct them by adjusting one or more of the values that contribute to that
total. To make any such adjustments, you will need to revisit the appropriate
budget period form(s) to enter corrected values.

PHS
398 Research Training Program Plan Components

Page
limitations must be followed as outlined in the SF424 (R&R) Application
Guide.

The Introduction for a resubmission application
is limited to three pages.

The Introduction for a revision application is
limited to one page.

Items 2-5 of the Research Training Program Plan
(Background, Program Plan, Recruitment and Retention Plan to Enhance
Diversity, and Plan for Instruction in the Responsible Conduct of
Research) are limited to a combined total of 25 pages, including additional
tables, graphs, figures, diagrams, and charts. The required data tables
are not included in the 25 page limit.

While each Item 2-5 needs to be uploaded
separately as a PDF attachment, applicants are encouraged to construct the
Items 2-5 as a single document, separating sections into distinct PDF
attachments just before uploading the files. This approach will enable
applicants to better monitor formatting requirements such as page limits. When validating for page limits, the eRA Commons will
not count the white space created by breaking the text into separate files
for uploading.

The
instructions for the Data Tables required for this FOA have been adapted to the
international focus of this FOA and are described below. The requested Data
Tables ( https://grants.nih.gov/grants/funding/424/index.htm) should be included in the application at the point indicated (PHS 398
Research Training Plan, 13. Data Tables) and should not be inserted in the
narrative for Sections 8.9.2-8.9.5. The
information in the data tables will be used by reviewers and NIH staff during
peer review and in reaching funding decisions.

Introduction (Item 1)

Required for Resubmission applications.

Background (Item 2)

Provide the rationale for the proposed research training
program; describe the relevant background and the need for the research
training proposed. Indicate how the proposed program relates to current
training activities at the applicant and collaborating institutions. Use this
section to document the environment in which the proposed training program will
take place.

Present an assessment of the needs for the research
training at the proposed low- or middle-income country (LMIC) institution(s).
The assessment should identify specific gaps in HIV research-related skills, and adjunct skills needed to address the
research agenda.

Describe how the
proposed research training and capacity building effort will help fill the
identified gaps and support the research training priorities of the LMIC.

Explain, in detail,
the relevance of the proposed research training to the
overall institutional development plan of the proposed LMIC institution.

Describe the prior
research and training collaborations between the key personnel at the applicant
institution(s) and any other proposed collaborating institution(s).

Provide evidence that faculty from the LMIC institutions collaborated
in creating the research training plan.

Identify areas of
mutual interest between the research priorities of the LMIC and the
co-sponsoring NIH Institutes, Centers or Offices identified on the FOA that will be supported through the proposed research
training.

Include
information relevant to the proposed training program for faculty from all
participating institutions and performance sites who will be involved in the
training program.

Program
Plan (Item 3)

Program administration: The
Training PD/PI must possess the scientific background and leadership and
administrative capabilities required to coordinate, supervise, and direct the
proposed research training program. The PD/PI will be responsible for the
overall direction, management, administration, and evaluation of the program. The PD/PI must submit
all required training information in a timely manner.

The program should have a Training Advisory Group (TAG) composed of
expert faculty from the applicant and collaborating countries who are not
directly involved in the training program or in
mentoring trainees. The TAG assists in trainee selection, scientific review of
trainee projects, and evaluation of trainees and training program progress.

In
addition to the Instructions forSF424
Application Guide:

Describe the
members of the TAG and the rationale for their
selection

Describe the specific responsibilities of the TAG and the
processes for it to accomplish its responsibilities. Each program should have
internal procedures in place that will provide independent peer-review for all training-related research projects.

When
describing the administrative structure of the program and the distribution of
responsibilities within it, include how the PD/PI will obtain continuing advice
with respect to the operation of the program from the TAG and what internal
procedures are in place for peer review of training-related research.

If multiple PDs/PIs are involved in the research training
program, applicants must describe how the research training program and
trainees will benefit from the arrangement and include the required Leadership
Plan. See Section III.1.B and Section IV.2 in this FOA for NIH multiple PD/PI
instructions: Multiple Principal Investigators, and
information in Section 8.7.10 of the Research Training Program Plan Component
Instructions.

Program
Faculty: Use
the following instructions, rather than those for this section in the Instructions forSF424 Application Guide.

This
section should describe the past research training record of the program, the
PD/PI, and designated preceptors/mentors. Include a description of the success
of former trainees, especially those from LMICs, in seeking further career
development and in establishing productive scientific careers.

Complete
per directions below and refer to data in Tables 4-6.
Use these tables to document the ability of the faculty to support the research
activities of the proposed trainees from LMICs and
the success of their trainees in generating publishable research results.

Complete Table 4. Grant and Contract Support of the Participating Faculty Members, include a list of
the active and pending research grants in which the PD/PIs, key or relevant
faculty at the collaborating institutions have played a key role. Include institution name with faculty member name. Please include
source of support and grant number (if applicable), grant title, project period
and current year direct costs. If the faculty member was not PI of the research
grant, indicate who was the PI and the role of the
faculty member in the Grant Title section.

In the narrative section, provide a short description of
the funded research in Table 4 that will serve as the research base for the
proposed research training program. Clearly identify the
grants that are being used for eligibility for this
FOA in Table 4 and in the narrative.

Complete Table 5. Pre and
Postdoctoral Trainees of Participating Faculty Members- Include trainee
information who are from LMICs (indicate the country) for participating faculty
from all collaborating institutions.

Complete Table 6. Publications
of Research Completed by Trainees (or Potential Trainees). For new applications, see the instructions for Table 6 in
Section 8.9.13 of the Instructions forSF424
Application Guide. For renewal
applications, only include trainee publications in peer-reviewed journals, including local journals, that
have been supported by the research training grant in the AITRPprogram and for which
the grant was cited. Do not include abstracts, not
yet accepted papers, or conference presentations and posters. These data constitute part
of the Progress Report (see item 6 Progress Report below).

Proposed Training:The program should plan to provide
didactic training and research experience relevant to the needs of the trainee
and proposed duration of training. This should include processes for
determining trainee prior experiences and for defining projected training needs
and a plan to monitor progress to accomplish desired goals. For long-term
trainees, the program should develop skills in understanding research, in
applying their critical abilities to conduct research, in identifying problems
in the process of conducting research, in raising questions and proposing
solutions to resolve problems. Trainees should be prepared to utilize
their research findings as they pursue future research. Programs should
provide all long-term trainees with additional professional development skills
and career guidance including instruction and training in grant writing in
order to apply successfully for future career development and independent
research support. All postdoctoral trainees should also be provided with
instruction in laboratory and project management.

Use
the following instructions, rather than those for this section in the Instructions forSF424 Application Guide for Section 8.

Describe the
proposed research training program, including the goals, objectives and how the
program will meet the objectives outlined in this FOA and the needs of the LMIC
and LMIC institution.

Describe a plan for
providing mentoring that will support trainees in
formal educational programs and in conducting training-related research.

Describe the plans
for the integration of the research capacity building activities at the LMIC
institution(s).

Describe how the
proposed research training program may serve as a
bridge among the academic research community, policy makers and public health
communities in the country.

Describe and
provide rationale for the balance of research training options (degree-related
and non-degree, long-, medium- and short-term
training) and disciplines to match the needs of the trainees and their LMIC
institution.

Describe plans to
include instruction about the inclusion of children, women and individuals from
underrepresented racial, ethnic and disadvantaged groups
in research conducted in their country.

Describe strategies
that will be used to achieve a wider regional impact. This could be done by
strengthening other institutions in the LMIC country or in neighboring countries ("south to
south" training).

Describe the plans for strengthening core research support
capabilities necessary for long-term sustainability, such as library science,
scientific writing and presentation, grant writing, bioinformatics, bioethics,
good clinical practice, good lab practice,
biosafety, data management, research administration, the management of
intellectual property and English as a second language.

Training Program Evaluation. In addition to the Instructions
forSF424 Application Guide:

The application should describe the system that will be used to track and document the long-term impact of
this training program on the research capacity of the LMIC institution(s). Ideally, trainees should be tracked for at least ten years
after completion of their training to assess the contribution of the training to their career development and the research
capacity of the LMIC institution..

Include a plan for data entry of trainee information into
CareerTrac, the web-based Fogarty Trainee Tracking System (see Section VI 3A
Additional Reporting Requirements below). CareerTrac will facilitate the tracking of trainees and
can be used to assist grantees to provide current trainee data and to describe examples of
career highlights of former trainees (awards, research grants, publications,
influences on policy, career advancements, etc.) in their annual progress reports.(see Section VI 3. Reporting below) and in renewal applications.

Applicants should develop a plan for self-evaluation of
their program, and establish some benchmarks and a
mechanism to periodically review the progress of their trainees and the
effectiveness of their program. This may consist of regular meetings among
faculty participating in the program and periodic review by the TAG and other
outside groups of consultants.

Evaluation metrics should eventually encompass measurement
of both the success of the individual trainees and the impact of the program on
research capacity at the LMIC institution. An evaluation of the research
training on individual and institutional levels will
be considered important criteria during any
re-competition of this FOA.

Trainee Candidates:This section should
describe the criteria, recruitment and selection procedures for trainees. The
long-term goal is to build a critical mass of researchers
and support staff with the combined expertise and skills to conduct research at
the LMIC institution. The TAG should be included in this process. Criteria
should include a list of standards that will be used to ensure that trainees
have appropriate prior training and experience, are
likely to complete the program, and are likely to return and develop into
productive independent researchers in their home country. The recruitment and
selection process must be transparent. Applications must identify a major role of the collaborating institutions in the
recruitment and selection plan.

Please
use the following instructions, rather than those for this section in the Instructions for SF424
Application Guide.

Describe the
characteristics of the trainees you plan to recruit
for each type of training proposed. Training may be offered to a wide range of
scientists, including laboratory scientists, clinicians, social scientists, and
other health professionals, as well as technical and administrative staff.

Provide a detailed description of the recruitment and
selection procedures and criteria for the foreign doctoral and post-doctoral
scientists and other beneficiaries of the research training program (short term
trainees, workshop participants, etc). Degree candidates
must meet all entrance requirements of the U.S. or foreign degree-granting institution. Thought should
also be given to preparation of long-term trainees in English language and/or
computer skills in the summer preceding studies in the U.S. or at the foreign site, where appropriate, to allow them to
make optimal use of their formal training period. Fees for such courses are
allowable costs.

Describe a plan for retaining students in the program until
completion.

Institutional
Environment and Commitment to the Program: Theadministration
of the applicant institution as well as all collaborating institutions should
include information in the application that documents institutional support and
commitment to the goals of the research training program. The application
should include a description of support (financial and otherwise) to be provided
to the proposed program. This could include, for example, space, shared
laboratory facilities and equipment, funds for curriculum development, release
time for the PD/PI and/or participating faculty, support for additional
trainees in the program, or any other creative ways to improve the climate for
the establishment and growth of the research training program.

Recruitment and Retention Plan to Enhance Diversity (Item
4): The NIH recognizes a unique and compelling need to
promote diversity in the domestic biomedical, behavioral, clinical and social
sciences workforce. The NIH expects efforts to diversify the workforce to lead
to the recruitment of the most talented researchers from all groups; to improve
the quality of the educational and training environment; to balance and broaden
the perspective in setting research priorities; to improve the ability to
recruit subjects from diverse backgrounds into clinical research protocols; and
to improve the Nation’s capacity to address and eliminate health disparities.

The FIC encourages the
research training programs supporting LMIC institution to consider ways to
promote the participation of individuals currently underrepresented in the
biomedical, clinical, behavioral, and social sciences in the LMIC as trainees
and faculty in the research training program.

Use the following
instructions, rather than those for this section in the Instructions for SF424 Application

Discuss plans to promote diversity relevant to the proposed
LMIC, rather than those defined within the U.S. context.

Applicants should
describe strategies for recruiting and retaining individuals from
groups underrepresented in the LMIC workforce. Such strategies may
address the representation of women and socially and economically disadvantaged
persons, among others as trainees and faculty.

Every
trainee supported by this training grant must receive instruction in the
responsible conduct of research. Describe the plan to provide trainees with
such instruction. The plan must address five components: format; subject
matter; faculty participation; duration of instruction; and frequency of
instruction. Renewal (Type 2) applications must, in addition, describe changes
in formal instruction over the past project period and plans for the future
that address any weaknesses in the current instruction plan. All training
faculty who served as course directors, speakers, lecturers, and/or discussion
leaders during the past project period must be named in the application

Progress
Report (Item 6): Use the following instructions, rather than those for this section in the Instructions forSF424 Application Guide.

This
component is not part of the 25-page limit. It
should focus on describing the activities and accomplishments that occurred in
the last grant period, but may include examples of career highlights of
trainees from former grant periods that occurred in the last grant period
(awards, research grants, publications, influences on policy, career
advancements, etc.). Data from CareerTrac can be used to assemble and report this information.

State
the periods covered and briefly describe the accomplishments of the training
program. Describe any specific effects of this training program on curriculum
and/or research directions in the collaborating institutions, both US and foreign. Describe how the research
training has increased the research capacity of the institution(s) in the LMIC
to address the research agenda around the priority
health needs of the LMIC.Describehow you have been able to leverage other NIH or non-NIH
program opportunities in the LMIC as a result of the research training.

You do not need to
complete Table
11Appointments to the Training
Grant For Each Year of the Past Award.

Trainees
without doctoral degrees who received medium- or long- term non-degree training
should be included and the non-degree training they received should be defined
on Table 12A. Do not list short-term trainees (less than 3 months of training)
on these tables.

CareerTrac will
facilitate the tracking of trainees and can be used to assist grantees to
provide trainee data for the progress report in the competing application and
accompanying data tables.

NOTE: Renewal applications: Reporting of information on completion rate
and time to degree for graduate students in doctoral degree programs that have
been supported by NIH training awards must be documented in the Program
Statistics section of Table 12A (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-141.html).
Information must include:

The percentage of such students admitted
for study who successfully attain a doctoral degree, and

The average time (not including leaves
of absence) for such students between the beginning of graduate study and
the receipt of a doctoral degree

Use the progress report
narrative to provide information that is not readily presented in the required
tables.

Describe each trainee, including country, training
received, any degrees awarded, training-related
research and post-training positions, assumed upon completion of training. Include a brief summary of the research conducted by
the trainee. For trainees continuing in training, provide a brief statement of
their status and progress toward completion of their training program.

Describe how the
applicant addressed the recruitment and support of women and socially
disadvantaged groups within the population of the LMIC.

Describe the
success of the program for the return of long-term trainees to their country of origin following the completion of their training and
describe the strategies used by the program to maximize the number of trainees
who return to their country of origin upon completing their training.

Describe how
returning trainees from your program are using their
research skills to strengthen the research capacity of their country and
influence policy decisions.

Include a list of
the research grants or other awards received by former trainees or in which
former trainees are playing key roles.

Give examples of any health policies that were influenced or
implemented by trainees in their home countries.

Refer to data presented in Table 6 Publications of Research Completed by Trainees (or Potential Trainees) as appropriate.

Follow the instructions in theSF424 Application Guide for items 7-12.

Data Tables (Item 13):https://grants.nih.gov/grants/funding/424/index.htm. The instructions above provide guidance
for completion of Data Tables 2, 4, 5, 6, which are required for all
applications. In addition, for renewal applications, Data Tables 12A and 12B
must be completed, using the instructions above. The information in the data
tables will be used by reviewers and NIH staff during peer review and in
reaching funding decisions. CareerTrac can be used to
assist grantees to provide trainee data in the required data tables.

Attach one pfd file
with all of the Data Tables (1-12B), although only Tables 2, 4, 5, and 6 are required for all applications, and, in
addition, Tables 12A and 12B for renewal applications for this FOA.

Letters of support (Item 14): Attach appropriate letters here from all individuals listed as Senior/Key
Personnel to confirm their roles in the project. Attach letters of support from
all of the participating institutions.

Appendix Materials (Item 15): Applicants must follow
the specific instructions on Appendix materials as described in the SF424
(R&R) Application Guide (See https://grants.nih.gov/grants/funding/424/index.htm).
A summary listing all of the items included in the appendix is required, and
should be the first PDF file. Applications that do not follow the appendix
requirements may be delayed in the review process. All appendix material must
be submitted as PDF attachments.

Research publications of trainees and mentors are not
normally included as part of the Training Grant applications, but are
allowed. Other types of publications reflecting on the activities of the
program as a whole may also be included. When publications are allowed,
appendix materials should be limited to those which are not publicly available,
such as:

Manuscripts and/or
abstracts accepted for publication but not yet published.

Published
manuscripts and/or abstracts where a free, online, publicly available
journal link is not available.

Patents directly
relevant to the project.

Do not include unpublished theses or
abstracts/manuscripts submitted, but not yet accepted, for publication.

Publications that are publicly accessible must not be
included in the appendix. For such publications, the URL or PMC submission
identification numbers along with the full reference should be included as
appropriate in the Bibliography and References Cited/Progress Report
Publication List section of the Research Plan, and/or in the Biographical
Sketch.

Some materials other than publications that are unique to
training grant applications (but not typically included in research grant
applications) may be included as appendices. The appendix may be used to
provide samples of materials that are referred to in the body of the
application, but are too cumbersome to include in the Training Program Plan
without disrupting the narrative flow. Examples include:

i. Additional tables not requested in the SF424 (R&R)
Application Guide instructions – designate these by letter, rather than number,
to avoid confusion with the numbered required tables;

iii. Retreat, seminar series, and other program activity
agendas, rosters, and schedules;

iv. Examples of forms used to document trainee progress
and monitoring by the program;

v. Examples of materials used in recruitment and
particularly recruitment and retention to enhance diversity of the student
pool.;

vi. Lists of meetings attended by students and their
presentations;

vii. Student biosketches; and

viii. Letters of support, collaboration, and commitment of
institutional resources.

Do
not use the Appendix to circumvent the page limitations. An application that
does not comply with the required page limitations may be delayed in the review
process.

Section V. Application Review Information

1.
Criteria

Only
the review criteria described below will be considered in the review process.

2.
Review and Selection Process

The
mission of the NIH is to support science in pursuit of knowledge about the
biology and behavior of living systems and to apply that knowledge to extend
healthy life and reduce the burdens of illness and disability. As part of
this mission, applications submitted to the NIH for grants or cooperative
agreements to support biomedical and behavioral research are evaluated for
scientific and technical merit through the NIH peer review system.

Review Process

Applications
submitted for this funding opportunity will be assigned on the basis of
established PHS referral guidelines to the ICs for funding consideration.

Applications that are
complete will be evaluated for scientific and technical merit by an appropriate
peer review group convened by CSR and
in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As part of the initial merit review, all applications
will:

May
undergo a selection process in which only those applications deemed to
have the highest scientific and technical merit will be discussed and
assigned an overall impact/priority score;

Will
receive a written critique; and

Will
receive a second level of review by the Fogarty International Center Advisory Board and the
appropriate national advisory council or board of co-sponsoring partners.

The goals of NIH-supported research training, education, and
programs are to help ensure that a diverse pool of highly trained
scientists is available in adequate numbers and in appropriate research areas to address the biomedical,
behavioral, and clinical research needs of LMICs.

Overall Impact

Reviewers will provide an overall impact/priority
score to reflect their assessment of the likelihood for the research training to exert a sustained, powerful influence on the research capacity of the partner LMIC institutions involved, in consideration of the following five scored
review criteria, and additional review criteria as applicable for the research training
proposed.

Scored Review Criteria

Reviewers
will consider each of the five review criteria below
in the determination of scientific and technical merit, and give a separate
score for each. An application does not need to be strong in all categories to
be judged likely to have scientific impact and contribute to the LMIC
institution’s ability to conduct and manage research to address the priority
problem(s) identified in the application.

Training
Program and Environment:

Are the expected
contributions of the proposed research training likely to strengthen the
ability of the LMIC institution to conduct research and research training of
importance to that country?

Do the objectives,
design, direction and mix of short-, medium- and long- term training of the
proposed program ensure effective research training?

Is there evidence of
a significant level of institutional commitment to the program from all the
participating institutions?

Is the Training
Advisory Group constructed to achieve the functions defined in this FOA?

How
successful is the history of institutional and individual collaborations among
the faculty of the participating institutions?

What is the likelihood that the described training will
contribute to sustainable research capacity at the LMIC institution?

Does the proposed
training program take advantage of the LMIC institution’s research
infrastructure and of previous and current investments and support from FIC,
NIH, and other organizations?

Does
the program provide training in inter- or multi-disciplinary research?

Does the applicant
demonstrate that research training being proposed will not be duplicative of
research training being provided by other AITRP awardees that provide research in
collaboration with the LMIC institution?

Will the proposed research training
strengthen the necessary administrative and management skills at the LMIC institution(s) and of the trainees to compete for future research support and
conduct research?

Has the applicant
described innovative strategies for trainees to become actively involved in
HIV-related research relevant to national health priorities conducted at the LMIC institution?

Training
Program Director/Principal Investigator (PD/PI):

Does the Training PD/PI have the
scientific background, expertise, and experience to provide strong leadership,
direction, management, and administration to the proposed research training
program?

Does the PD/PI plan to commit
sufficient time to the program to ensure its success?

Is sufficient administrative and
research training support provided for the program?

Does
the on-going research at the LMIC site required for eligibility provide an
adequate research platform for the proposed research training?

For applications designating
multiple PD/PIs:

Is a strong justification
provided that the multiple PD/PI leadership approach will benefit the training
program and the trainees?

Is a strong and compelling
leadership approach evident, including the designated roles and responsibilities,
governance, and organizational structure consistent with and justified by the
aims of the training program and with the complementary expertise of each of
the PD/PIs?

Preceptors/Mentors:

Are sufficient numbers of
experienced preceptors/mentors with appropriate expertise and funding available
to support the number and level of trainees proposed in the application?

Do the preceptors/mentors have
strong records as researchers, including successful competition for research
support in areas directly related to the proposed research training program?

Do the preceptors/mentors have
strong records of training pre- and/or postdoctoral scientists from low-and
middle-income countries?

Trainees:

Is a recruitment
plan proposed with strategies to attract high quality trainees?

Are there
well-defined and justified selection criteria and retention strategies?

Is there
evidence of a competitive applicant pool in sufficient numbers to warrant
the proposed size and levels (predoctoral, postdoctoral and/or short-term)
of the training program?

For applications
that request short-term research training for predoctoral and/or
postdoctoral level positions, does the program have the potential or
evidence to recruit high quality, short-term trainees?

For renewal
applications, how successful has the program been in attracting and
retaining individuals from diverse populations, including populations
underrepresented in science?

Training
Record:

How successful are the trainees (or for new applications, other
past students/fellows in similar training) in completing the program?

How productive are trainees (or for new applications other past
students/fellows) in terms of research accomplishments and publications?

How successful are trainees (or other past students/fellows) in
obtaining further training appointments, fellowships, and/or career development
awards?

How successful are the trainees in achieving productive scientific
careers, as evidenced by successful competition for research grants, receipt of
honors or awards, high-impact publications, receipt of patents, promotion to
scientific leadership positions, and/or other such measures of success?

For programs that provide research training to health-professional
doctorates, is there a record of retaining health professionals in research
training or other research activities for at least two years?

Does the program have a rigorous evaluation plan to assess the
quality and effectiveness of the training?

Are effective mechanisms in place for obtaining feedback from
current and former trainees and monitoring trainees’ subsequent career
development?

For renewal applications:

Does the
application describe the program’s accomplishments over the past funding
period(s);

Are
changes proposed that would improve/strengthen the training experience?

For applications that request short-term research training
positions:

Are plans
presented to follow the careers of short-term trainees and to assess the effect
of the training program on subsequent career choices?

What is
the success in attracting students back for multiple appointments?

What is
the effect of the short-term component on the overall training program?

What is the expected ability of the proposed training plan
to maximize the return and integration of trainees into relevant HIV-relatedresearch at the LMIC institution(s) to build sustainable
research capacity?

Does the program
have a rigorous evaluation plan to review the quality and effectiveness of the
training?

How adequate is the proposed method to monitor the
long-term impact of the HIV-relatedresearch training experience on the subsequent careers of
the trainees and the HIV-relatedresearch capacity at the LMIC institution?

Additional Review Criteria

As
applicable for the program proposed, reviewers will consider the following additional items in the
determination of scientific merit, but will not give separate scores for these
items.

Protections for Human
Subjects. For research that involves human subjects but does not
involve one of the six categories of research that are exempt under 45 CFR Part
46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves
human subjects and meets the criteria for one or more of the six
categories of research that are exempt under 45 CFR Part 46, the committee will
evaluate: 1) the justification for the exemption, 2) human subjects involvement
and characteristics, and 3) sources of materials.

Inclusion of Women,
Minorities, and Children.When the proposed project involves
clinical research, the committee will evaluate the proposed plans for inclusion
of minorities and members of both genders, as well as the inclusion of
children.

Vertebrate
Animals.The committee will evaluate the involvement of
live vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information to assist you in determining if the Vertebrate Animals
section is “Acceptable” or “Unacceptable”, please refer to Vertebrate Animals
checklist.

Biohazards:Reviewers
will assess whether materials or procedures proposed are potentially hazardous
to research personnel and/or the environment, and if needed, determine whether
adequate protection is proposed.

Resubmission
Applications:When reviewing a Resubmission
application (formerly called an amended application), the committee will
evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the program.

Renewal
Applications:When reviewing a Renewal application
(formerly called a competing continuation application), the committee will
consider the progress made in the last funding period. In addition, the
committee will consider the following:

Does the
renewal application describe the program accomplishments over the past funding
period(s), such as information on trainee publications, degree completion, and
post-training positions?

Has the
program been adequately evaluated, and has the level of success been
satisfactory?

Are changes
proposed that would improve/strengthen the training experience?

Are there plans to make changes to
improve program performance and incorporate feedback from current and former
trainees (e.g., new mentors changes in courses, recruitment strategies, etc.)?

Additional
Review Considerations

As
applicable for the program proposed, reviewers will address each of the
following items, but will not give scores for these items and should not
consider them in providing an overall impact/priority score.

Diversity Recruitment and Retention Plan: Peer
reviewers will separately evaluate the diversity recruitment and retention plan relevant to the proposed LMIC, rather than diversity as
defined within the U.S. context after the overall score has been determined. Reviewers will examine the strategies
to be used in the recruitment and retention of individuals currently
underrepresented in the biomedical, clinical, behavioral, and social sciences
in the LMIC. Such strategies may address the representation of women and
socially and economically disadvantaged persons, among others as trainees and
faculty.

Training
in the Responsible Conduct of Research: Reviewers will evaluate plans for
instruction in responsible conduct of research as well as the past record of
instruction in responsible conduct of research, where applicable. Reviewers
will specifically address five Instructional Components, Format, Subject
Matter, Faculty Participation, Duration and Frequency, taking into account the
characteristics of institutional programs, detailed in NOT-OD-10-019. Plans and past record
will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with
unacceptable plans will not be funded until the applicant provides an
acceptable, revised plan.

Select
Agents Research: When applicable, reviewers will
assess the information provided in the application, including 1) the Select
Agent(s) to be used in the proposed research training program, 2) the
registration status of all entities where Select Agent(s) will be used, 3) the
procedures that will be used to monitor possession use and transfer of Select
Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security
of the Select Agent(s).

Budget
and Period of Support: Reviewers will consider whether the budget and the requested period of
support are fully justified and reasonable in relation to the proposed
institutional research training and the number of proposed trainees at the
requested levels.

Selection Process

Applications submitted in
response to this funding opportunity will compete for available funds with all
other recommended applications. The following will be considered in making
funding decisions:

Scientific and technical merit of the
proposed project as determined by scientific peer review.

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., “Funding Restrictions.”

Follow
the instructions for the Non-Competing Grant Progress Report for institutional
research training grants in Form 2590. Use the budget pages in the PHS2590 that
correspond to the budget pages submitted for the application to submit the
budget for the next budget period. Use the instructions included in this FOA to
guide you in requesting the budget for the next budget period. Include a budget
justification. Note that a summary of the trainee page is to be included in the
request for continuation support. The non-competing budget page should list the
names and levels of those trainees who are continuing in the research training
program. Tables 12A and 12B should be completed following the guidance
provided in this FOA. The Trainee Diversity Report is not required. Additional
information that should be provided in the annual progress report in concert
with the PHS 2590 instructions includes:

A brief
introductory description of the program objectives.

A brief narrative
description for each trainee (current trainees and those who completed
training in the previous budget period) as described in the PHS Form 2590
instructions, and career highlights of trainees from former grant periods
that occurred in the last budget period (awards, research grants,
publications, influences on policy, career advancements, etc.). CareerTrac
will facilitate the tracking of trainees and can be used to
download and printing of some of the requested tables for annual progress
reports and renewal applications.

Information
describing which, if any, collaborators, faculty and/or mentors have left
the program and which, if any, new individuals have been added. For new collaborators,
faculty and/or mentors involved in the program, biographical sketches
should be included in the application. Please note that new countries
cannot be added without prior approval.

Any recommended
changes to improve the program, including those resulting from feedback
from current or former trainees (e.g. new mentors, changes in courses,
recruitment strategies, etc.)

Information as to
how the training program has addressed the interest of the co-sponsors.

3.A. Additional Reporting
Requirements

Financial Status Report
(FSR): An annual FSR is required and
must be submitted within 90 days of the end of each budget period. Continuation
support will not be provided until the required form is submitted and accepted.

Peer-reviewed
trainee publications that arise from support of the training grant must be
submitted to PubMed Central in accord with the Public Access Policy, and the
PubMed Central reference number (PMCID) or NIH Manuscript Submission reference
number (NIHMS ID) provided. If the publication was already submitted because it
also arose as the result of other NIH support, simply provide the PMCID or
NIHMS ID. If the PMCID is not yet available because the Journal submits
articles directly to PMC on behalf of their authors, indicate "PMC Journal
- In Process." A list of these Journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm

Publication and Sharing
of Research Results: NIH
supports the practical application and sharing of outcomes of funded
research. Therefore, trainees should make the results and accomplishments
of their research training activities available to the research community and
to the public at large. The grantee organization should assist trainees
in these activities, including the further development of discoveries and
inventions for furthering research and benefiting the public. No
restrictions should be placed on the publication of results in a timely manner.

Trainees are encouraged to
submit reports of their findings for publication to the journals of their
choice. For each journal publication that results from a trainee’s
research, NIH support should be acknowledged in language similar to the
following: “This investigation was supported by the Fogarty International
Center, (add NIH co-sponsoring institutes, centers or offices for the grant) of
the National Institutes of Health under the AIDS International Training and Research Program (grant number).” In
addition, news releases and other documents about the project must acknowledge federal
funding as provided in “Public
Policy Requirements and Objectives-Availability of Information-Acknowledgment of
Federal Funding.”

Evaluation: In carrying out its stewardship of human
resources-related programs, the NIH may request information essential to an
assessment of the effectiveness of this Program. Accordingly, trainees should
be notified that they may be contacted after the completion of their training
for periodic updates on various aspects of their employment history,
publications, support from research grants or contracts, honors and awards,
professional activities, and other information helpful in evaluating the impact
of the research training program.

Inventions: Traineeships made primarily for educational
purposes are exempted from the PHS invention requirements and thus invention
reporting is not required for institutional training grants. However, please
report any inventions or patents funded under the research training grant.

Copyrights: Except as otherwise provided in the terms and
conditions of the award, the recipient is free to arrange for copyright without
approval when publications, data, or other copyrightable works are developed in
the course of work under a PHS grant-supported project or activity. Any such
copyrighted or copyrightable works shall be subject to a royalty-free,
nonexclusive, and irrevocable license to the Government to reproduce, publish,
or otherwise use them, and to authorize others to do so for Federal Government
purposes.

Final Reports: A Final Progress Report and Financial Status
Report are required at the end of the grant project period or upon
relinquishment of an award. Evaluation results should be included as part
of the Final Progress Report.

Human Embryonic Stem
Cells (hESC): Only approved
hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research
training activities. The abstract of the application must provide the registry
identifying numbers of the HESC lines to be used.

Section
VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research (program), peer review, and financial or
grants management issues:

Human Subjects
Protection:Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (“NIH Policy for
Data and Safety Monitoring,” NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing
Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (https://grants.nih.gov/grants/policy/data_sharing).Investigators should
seek guidance from their institutions, on issues related to institutional
policies and local institutional review board (IRB) rules, as well as local,
State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see https://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women And Minorities in Clinical
Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy,investigators
funded by the NIH must submit or have submitted for them to the
National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication that
are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and
Regulations:This program is described in
the Catalog
of Federal Domestic Assistance athttp://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Loan
Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.